SAN DIEGO, Sept. 24, 2015 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced the upcoming presentation of results from two of its programs; Phase 3 trials evaluating AuriProTM in pediatric patients with middle ear effusion undergoing tympanostomy tube placement surgery, and a Phase 2b trial evaluating OTO-104 in patients with unilateral Ménière's disease. Clinical results from these studies will be presented at the 2015 American Academy of Otolaryngology - Head & Neck Surgery Foundation (AAO-HNSF) Annual Meeting being held in Dallas on September 27-30, 2015. The results for both programs have been previously announced or presented.
Paul R. Lambert, M.D., Professor and Chair, Department of Otolaryngology, Medical University of South Carolina, will present the OTO-104 data on Monday, September 28, in a presentation titled, "Phase 2b Efficacy and Safety of Intratympanic OTO-104 in Ménière's Disease." The presentation will take place in the East Fork Room in the Kay Bailey Hutchison Convention Center at 8:18 a.m. CDT.
Albert H. Park, M.D., Division Chief Pediatric Otolaryngology, Professor in Department of Surgery and Pediatrics, University of Utah, will present the AuriPro (OTO-201) data on Monday, September 28, in a presentation titled, "Efficacy from Combined Analysis of Two Phase 3 Trials of Ciprofloxacin Thermosensitive Gel in Pediatric Subjects Getting Ear Tubes." The presentation will take place in the Trinity Ballroom 1 in the Omni Dallas Hotel at 3:30 p.m. CDT.
AuriPro is a sustained-exposure formulation of the antibiotic ciprofloxacin in development for the treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery. AuriPro has been formulated to provide sustained-exposure of ciprofloxacin so that a single administration provides a full course of treatment. There are approximately one million TTP surgeries performed each year in the United States, and antibiotic ear drops are used in nearly all cases. Despite their routine use, no antibiotic ear drop has received FDA approval for this indication. Moreover, current ear drop products require multi-dose, multi-day regimens for efficacy. Full compliance with these regimens can be challenging, and missed antibiotic doses can compromise efficacy and increase the potential for bacterial resistance.
The U.S. Food and Drug Administration (FDA) has assigned a PDUFA action date of December 25, 2015 for the company's New Drug Application (NDA) for AuriPro for the treatment of middle ear effusion in pediatric patients undergoing TTP surgery. If approved within the standard review period, Otonomy anticipates a commercial launch for AuriPro in the United States in the first quarter of 2016. AuriPro is also being evaluated for two potential label expansion indications; a Phase 2 feasibility trial has been completed in pediatric patients with acute otitis media with tympanostomy tubes (AOMT), and a Phase 2 feasibility trial is ongoing for patients with otitis externa (swimmer's ear).
OTO-104, which has been granted Fast Track designation by FDA, is a sustained-exposure formulation of the steroid dexamethasone in development for the treatment of Ménière's disease and other inner ear conditions. Otonomy has completed a randomized, prospective, double-blind, placebo-controlled single-dose Phase 2b trial in a total of 154 Ménière's disease patients. Results indicate that OTO-104 narrowly missed the primary efficacy endpoint (p=0.067) but achieved statistical significance (p<0.05) for multiple prospectively defined secondary vertigo endpoints at multiple time points. Based on these results Otonomy intends to initiate two parallel Phase 3 trials, with one of the trials expected to begin by the end of 2015 and the second trial expected to begin during the first quarter of 2016. OTO-104 is also being evaluated in a multiple-dose safety study in the United Kingdom in patients with Ménière's disease, and enrollment has been completed with a total of 128 patients.
Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. Otonomy's proprietary technology provides sustained exposure of drugs to the ear following a single administration. Otonomy has three product candidates in development. AuriPro™ is an antibiotic that has completed Phase 3 clinical trials in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery, and the FDA has assigned a PDUFA action date of December 25, 2015 for the company's New Drug Application. OTO-104 is a steroid that has completed a Phase 2b clinical trial in 154 patients with Ménière's disease. Based on these results, Otonomy intends to initiate two parallel Phase 3 trials for OTO-104 in Ménière's disease patients with at least one trial initiated by the end of 2015. OTO-311 is an NMDA receptor antagonist in development as a treatment for tinnitus. For additional information please visit www.otonomy.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Otonomy's future financial or operating performance. Forward-looking statements in this press release include, but are not limited to, the initiation, timing and design of Otonomy's Phase 3 clinical trials with OTO-104 and the timing of the launch of AuriPro™. Otonomy's expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the preclinical and clinical results for its product candidates, which may not support further development of product candidates, and challenges related to patient enrollment in clinical trials; Otonomy's ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy's product candidates; developments related to competitors and the industry; Otonomy's dependence on third parties to conduct preclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of products; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to product candidates in the United States and throughout the world; and other risks. Otonomy undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
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